Label: TEA TREE ANTISEPTIC- tea tree oil ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated August 27, 2013

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  • Active ingredient

    Melaleuca Alternifolia (Tea Tree) Leaf Oil 5%

  • Purpose

    First Aid Antiseptic

  • Uses

    First aid to help protect against infection in minor cuts, scrapes and burns.

  • Warnings

    For external use only

    Do not Use

    • in the eyes or apply over large areas of the body
    • longer than 1 week unless directed by a doctor.

    Ask a doctor before use if you have

    deep or puncture wounds, animal bites, or serious burns.

    Stop use and ask a doctor if

    condition persists or worsens.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • clean the affected area
    • apply small amount two or three times a day
    • may be covered with a sterile bandage.
  • Other information

    • store below 86 F.
  • Inactive ingredients

    Paraffin white soft, Mineral oil, Cetostearyl alcohol, dl-alpha tocopheryl acetate

  • DESCRIPTION

    DISTRIBUTED BY: Integria Healthcare (US) Inc., Paramount CA 90723-3426.

    USA Health Food: Natural Organics Inc, 548 Broadhollow Road Melville NY 11747

    MADE IN AUSTRALIA

  • Principal Display Panel

    NDC 51257-642-02

    Thursday Plantation

    Australia's Original

    TEA TREE ANTISEPTIC OINTMENT

    First aid to help protect

    against infection in minor

    cuts, scrapes and burns

    Net Wt 1.76 oz (50 g)


    TT Antiseptic Ointment label



  • INGREDIENTS AND APPEARANCE
    TEA TREE ANTISEPTIC  
    tea tree oil ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51257-642
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TEA TREE OIL (UNII: VIF565UC2G) (TEA TREE OIL - UNII:VIF565UC2G) TEA TREE OIL50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51257-642-0250 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/27/2013
    Labeler - Integria Healthcare (US) Inc (962379454)
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